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510(k) K200754

Hemosure Accu-Reader A100 by W.H.P.M., Inc. — Product Code OOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2022
Date Received
March 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Occult Blood Analyzer
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.

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Other clearances for product code OOX

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